Pilot Study of an Aerobic Exercise Intervention During Immune Checkpoint Inhibitor Therapy in Early-stage Triple Negative Breast Cancer

NCT ID: NCT07216495

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-06
• Study Completion Date: 2030-10-30

Brief Summary

To learn if participating in a supervised exercise program can help participants with early-stage TNBC who are receiving ICI therapy before undergoing breast surgery.

Detailed Description

Primary Objective To evaluate the feasibility of a supervised cardiorespiratory exercise program in participants with clinical stage 2-3 Triple Negative Breast Cancer (TNBC) undergoing neoadjuvant chemotherapy with immune checkpoint inhibitor therapy.

Secondary Objectives To explore the relationship between cardiorespiratory exercise and circulating immune (CD8+ T) cells in the peripheral blood.

Conditions

Aerobic Exercise; Early Stage Triple Negative Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Acute cardiorespiratory exercise program

consisting of 4 in-clinic exercise sessions

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

Cardiorespiratory training via treadmill walking for 30 minutes; participants will be supervised by a trained exercise physiologist.

Interventions

Exercise

Cardiorespiratory training via treadmill walking for 30 minutes; participants will be supervised by a trained exercise physiologist.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. female and male participants 18 years or older and willing to provide Informed Consent

2. clinical stage 2 or 3 TNBC (estrogen receptor and progesterone receptor ≤ 10% by immunohistochemistry (IHC) and human epidermal growth factor-2 (HER2) negative (IHC 0, IHC1+, or IHC 2+ with negative fluorescence in situ hybridization))

3. Physically able to walk independently without assistive device and able to march in place for 30 seconds without assistive device

4. Eastern Co-Operative Oncology Group (ECOG) Performance Status 0-1

5. Planned receipt of neoadjuvant chemoICI therapy (carboplatin/taxane in combination with pembrolizumab; taxane options are weekly paclitaxel or every 3 week docetaxel8,46)

6. clearance to participate in the study by the patient's medical oncologist

7. normal bone marrow function

8. able to read/complete study forms/assessments and understand instructions in English

Exclusion Criteria

a) Any physical condition which hinders the ability to safely participate in exercise including: uncontrolled or symptomatic cardiac/respiratory disease (e.g. uncontrolled angina, unusual shortness of breath, congestive heart failure, symptomatic peripheral vascular disease), stroke/myocardial infarction in the past year, fragility fracture, recent or planned orthopedic surgery, or any comorbid condition precluding exercise per the treating physician b) receipt of medications known to influence immune function including corticosteroids (>10 mg prednisone equivalent), other immune-suppressive medication, or beta blockers47 c) Any infection or vaccination within the last 4 weeks d) e) Known HIV-positive participants on combination antiretroviral therapy f) concurrent participation in a therapeutic clinical trial or other exercise program g) pregnant h) medically advised to not exercise i) Unable to walk on a motor-driven treadmill for ~30 minutes at study enrollment j) Adults unable to consent k) No external catheters/drains (e.g., nephrostomy tube, foley catheter). A colostomy or Ileostomy is acceptable.

l) Prior or concurrent non-breast malignancy. Those with prior cancers treated with curative intent are eligible. Participants with known (or history) of hepatitis B positive, or hepatitis C positive infection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jasmine Sukumar, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Central Contacts

Jasmine Sukumar, MD

Role: CONTACT

jsukumar@mdanderson.org

(713) 264-1576

Johana Campos

Role: CONTACT

JCampos1@mdanderson.org

713-563-0977

Facility Contacts

Jasmine Sukumar, MD

Role: primary

jsukumar@mdanderson.org

713-264-1576

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

NCI-2025-07495

Identifier Type: OTHER

Identifier Source: secondary_id

2025-1303

Identifier Type: -

Identifier Source: org_study_id